The Local Ethical Committee approval was not required because the procedure was commonly employed in the clinical practice.

All couples (female and male partners) signed an informed consent before the screening procedures for enrolment.

But according to the retraction notice, an investigation by the hospital, home to the Italian researchers, came to a different conclusion:

Contrary to the statement in the article that ethics committee approval was not required, an investigation by the Arcispedale Santa Maria Nuova-IRCCS has determined that the study should have been reviewed and approved by an ethics committee. All authors agree with this retraction.

The story may not end there. The paper’s last author, Stefano Palomba, told Retraction Watch that the investigation was the result of internal politics at Arcispedale Santa Maria Nuova-IRCCS:

This is a ugly story born to discredit my boss, Prof. [Giovanni Battista] La Sala, after the election of the new Scientific Director.

However, Palomba declined to provide more detail about the alleged power play. La Sala was the paper’s first author; he did not respond to Retraction Watch’s request for comment.

The study compared two versions of an assisted reproductive technology (ART) used to boost the chances of conception: conventional intracytoplasmic sperm injection (cICSI) and intracytoplasmic morphologically selected sperm injection (IMSI). In both techniques, a technician selects better looking sperm through a microscope; however, IMSI uses a higher powered microscope and looks at additional criteria. A review paper on IMSI from 2011 said:

Although IMSI has not yet been standardized and requires further validation, it can be considered one of the most promising issues in the ART field.

According to the paper, which has been cited once, per Clarivate Analytics’ Web of Science, 48 out of 121 couples in the study received IMSI instead of cICSI between May 2011 and September 2012, when the researchers shut down enrollment. The hospital’s Infertility Centre performs approximately 1,500 in vitro fertilization procedures per year, the paper said. The authors added:

At study design, the trial was not recorded on any international register available online. Thus, an international registration number is not actually available.

The patients’ enrolment was stopped prematurely in September 2012 on the advice of the data safety and monitoring Committee because of concerns about IMSI efficacy at the third interim analysis. In fact, a significant and unexpected lower fertilization rate was observed in IMSI arm when compared to cICSI arm.

There’s no indication that the study’s termination had anything to do with the investigation. Arcispedale Santa Maria Nuova-IRCCS has not yet responded to our request for comment on the investigation. We’ll update the story if we find out more.

Palomba agreed that he and his co-authors “signed a template for the retraction” but he reiterated they didn’t need ethics oversight. He told us:

the experimental procedure was already accepted as routinary by the Clinical Direction of our institution….

So let me get this right. I can keep collecting the records of different things that happen in the clinic. But if want o analyze it I need IRB approval ? Most of these are retrospectively analysed routine data and not actual trials. We are stretching many things and too literally.